Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy
Status:
Recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
Summary
Immunotherapy (checkpoint inhibitors) is approved as first and second line treatment to
patients with metastatic bladder cancer. However, response rates are low and no biomarkers
have yet shown strong predictive value for patient selection. Moreover, the term 'metastatic'
is based on metastases visible on conventional CT scans and, thus, require a certain size of
tumour load. Clinical trials are currently being conducted that investigate the use of
adjuvant immunotherapy for this group of patients (treatment to all), which will result in
massive over-treatment and huge costs to the healthcare system.
This project has the primary objective to identify new indications for initiating
immunotherapy in patients with metastatic bladder cancer. Sensitive molecular techniques for
detection of tumor DNA in the blood will be used to identify patients with early signs of
metastatic disease. In addition, comprehensive biomarker analysis will be performed to
identify predictors of treatment response.
Phase:
Phase 2
Details
Lead Sponsor:
Jørgen Bjerggaard Jensen
Collaborators:
Aalborg University Hospital Aarhus University Hospital Herlev Hospital Odense University Hospital Rigshospitalet, Denmark